POS0846 EFFICACY, SAFETY, AND RECURRENCE OF IGURATIMOD COMBINED WITH CSDMARDS TREATMENT IN RHEUMATOID ARTHRITIS: A PROSPECTIVE REAL-WORLD STUDY
Authors: Q. Che, X. Liu, X. Qi, Y. Li, X. Zhang, H. Wang, Q. Shu
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Iguratimod (IGU) is widely used in the treatment of rheumatoid arthritis (RA) and has been considered the first-line treatment option in many countries. The efficacy and safety of IGU combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) therapy have been confirmed by many studies <sup>[1]</sup>. Only a few studies focused on the long-term efficacy and safety of IGU treatment, and the maintenance strategy after short-term remission (REM) still needs to be explored. <h3>Objectives</h3> To observe the long-term efficacy, safety, and recurrence of IGU combination with csDMARDs in the treatment of active RA and the characteristic of patients who obtain the most benefit from IGU. <h3>Methods</h3> The study was conducted in China (ClinicalTrials.gov ID: NCT03855007). Patients who matched the 2010 ACR/EULAR RA criteria or the 2014 early rheumatoid arthritis (ERA) criteria <sup>[2]</sup> were recruited. According to patientsicalTrials.gov ID: NCT03855007). Patients who matched the 2010 ACR/EULAR RA criteria or the 2014 early rheumatoid arthritis (ERA) criteria enefit from IGU.on with conventiond follow-up from baseline to week 96 regularly. We divided them into three groups according to whether and when to reduce the drugs: maintained (MA), reducing the dose of IGU, MTX, and LEF after (AF) or before (BF) low disease activity (LDA), or REM was achieved. The proportion of LDA or REM of DAS28-ESR achieved at week 96, the ratio of ACR20, ACR50, ACR70, the recurrence (loss of LDA status and the increase of DAS28-ESR ≥ 0.6 <sup>[3]</sup>), and the occurrence of adverse events (AE) were investigated. The chi-square test or long-rank test analyzed the corresponding statistical differences. <h3>Results</h3> A total of 246 patients were enrolled in this study, and 131 (53.3%) participants completed the 96-week follow-up. Efficacy analysis found that the proportion of achieving ACR20 reached a plateau after 24 weeks, while there was a sustained increase in the LDA and REM ratio of DAS28-ESR (week 24: 57.25% vs. week 96: 68.70%, p = 0.06), ACR50 (66.41% vs. 77.86%, p = 0.01) and ACR70 (22.90% vs. 41.98%, p &lt; 0.01) (<b>Figure 1 A, B</b>). Further subgroup analysis revealed the expected effects of age, gender, and disease duration on whether achieved the LDA or REM at 96 weeks. Moreover, the time of IGU, MTX, and LEF reduction also played an essential role in long-term treatment. There was no difference in the improvement of DAS28-ESR between the MA (n=15) and reduction (AF+BE) groups. We found that patients in the AF group (n=73) were able to achieve and maintain LDA or REM and ACR50 responses better than the BE group (n=43) (<b>Figure 1 C</b>). There was no statistical difference in the incidence of AE between BE and AF groups (p = 0.44). During the follow-up period, 48 patients had a relapse of the disease in the AF and BE groups. The subgroup analysis found that drug reduction after REM was more recommended in patients with a diagnosis of RA (vs. ERA), disease duration ≥ 2 years, age &lt; 45 years, and morning stiffness &lt;1 hour (<b>Figure 1 D</b>) for maintaining long-term LDA or REM (p &lt; 0.05). <h3>Conclusion</h3> The RA patients could achieve deeper REM and sustained after long-term treatment of IGU combination with csDMARDs. LDA or REM should be achieved before reducing the dose of IGU and csDMARDs, especially for the long-course, younger, with shorter morning stiffness RA patients. <h3>References</h3> [1]Mu R, Li C et al. Lancet Reg Health West Pac 2021, 10:100128. [2]Zhao J, Su Y et al. Clin Exp Rheumatol 2014, 32(5):667-673. [3]Smolen JS, Nash P et al. Lancet 2013, 381(9870):918-929. <h3>Acknowledgements</h3> Funded by the ECCM Program of Clinical Research Center of Shandong University (No. 2021SDUCRCB010), the Horizontal Project of Shandong University (No. 6010120019) and the Natural Science Foundation of Shandong Province (ZR2022MH177). <h3>Disclosure of Interests</h3> Qincheng Che: None declared, XinLei Liu: None declared, Xiaoyan Qi: None declared, Yanmei Li: None declared, Xiaojie Zhang: None declared, Hui Wang Employee of: Jiangsu Simcere Pharmaceutical Co., Ltd., Qiang Shu: None declared.